A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants (El Porto Ex-US)
2026年6月25日 更新者：Kenvue Brands LLC
A Monocentric and Open-Label Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Research Participants
The study aims to evaluate the efficacy of a facial sunscreen under two experimental conditions-untinted and tinted-in improving facial spots (melasma and solar lentigines/post-inflammatory hyperpigmentation) after 8 weeks of product use under normal conditions by adult participants.
研究概览
研究类型
介入性
注册 (估计的)
152
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Kenvue Global Clinical Operations
- 电话号码：18779295131
- 邮箱：KenvueClinical_KV@kenvue.com
学习地点
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São Paulo
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Campinas、São Paulo、巴西、13084-791
- 招聘中
- ALS Beauty & Personal Care Ltda
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接触：
- Gabrielli Brianezi
- 电话号码：+551937898600
- 邮箱：gabrielli.brianezi@alsglobal.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Able to understand and follow study instructions
- Fitzpatrick skin types I-VI
Presence of facial hyperpigmentation, such as:
- Mild to moderate melasma, or
- Visible dark spots (e.g., solar lentigines or post-inflammatory hyperpigmentation)
- Willing to comply with study procedures and product use
- For subjects in applicable groups: willing to use assigned sunscreen product
Exclusion Criteria:
- Known sensitivity or allergy to cosmetic or skincare products
- Skin conditions or lesions in the study area that could interfere with evaluation (e.g., active dermatitis, infections, significant irritation, or extensive scarring)
- Use of medications or products that may interfere with study evaluations
- Recent cosmetic or dermatological procedures in the study area (e.g., chemical peels, laser treatments, invasive procedures)
- Excessive sun exposure or use of tanning beds immediately prior to or during the study
- Pregnancy or intention to become pregnant during the study
- Participation in another clinical study within a recent period
- Any condition or situation that, in the investigator's judgment, may interfere with study participation or evaluation of results
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Group I: Melasma/Untinted
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Participants will apply the facial sunscreen on the face at least twice daily for 56 days
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实验性的：Group I: Melasma/Tinted
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Participants will apply the facial sunscreen on the face at least twice daily for 56 days
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实验性的：Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Untinted
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Participants will apply the facial sunscreen on the face at least twice daily for 56 days
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实验性的：Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Tinted
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Participants will apply the facial sunscreen on the face at least twice daily for 56 days
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical efficacy of change in hyperpigmentation assessed via dermatological evaluation
大体时间：Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Instrumental measurements with the Chroma Meter CR 400 (Konica Minolta)
大体时间：Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Measurements will be taken using the Chroma Meter® CR 400 to evaluate the color intensity of the dark spot (Melasma, Solar Lentigo, or Post-Inflammatory Hyperpigmentation) in comparison to the measurement of an adjacent area (without a spot).
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Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Capture of facial images using the Visia-CR® Facial Imaging Booth (Canfield Scientific, Inc.)
大体时间：Before, immediately after the first application, and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Facial images will be captured using the Visia CR® Facial Imaging Booth (Canfield Scientific, Inc.) for analysis of the intensity and size of the spot (Melasma, Solar Spot, or Post-Inflammatory Hyperpigmentation), as well as the overall uniformity of skin tone.
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Before, immediately after the first application, and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Participants' quality of life regarding facial spots for participants with Melasma assessed through a Quality of Life Questionnaire (MELASQoL)
大体时间：Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Melasma Quality of Life Scale (MELASQoL) will only be answered by participants enrolled in Melasma group. The participant will answer a questionnaire with 10 questions regarding the condition of their skin, using a rating scale from 1 to 7, in which: 1 means "not at all bothered" and 7 means "bothered all the time". A total score will be generated by summing the scores of the 10 questions answered by the participant. The total score ranges from 10 to 70. The lower the score, the better the participant's quality of life. |
Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Participants' quality of life regarding facial spots for participants with Solar Lentigo or Post-Inflammatory Hyperpigmentation assessed through a Quality of Life Questionnaire (DLQI)
大体时间：Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Dermatology Life Quality Index (DLQI) will only be answered by participants selected for the Solar Lentigo/PIH Group.
The participant will answer a questionnaire with 10 questions regarding the impact of their skin on their quality of life.
Each question is scored on a four-point Likert scale: very much = 3 points, much = 2 points, a little = 1 point and nothing/not relevant = 0 points.
Questions answered as nothing and not relevant are equivalent to 0 points.
The total score ranges from 0 to 30.
The lower the score, the better the participant's quality of life.
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Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Perceived efficacy assessed through perception questionnaires completed by the research participants
大体时间：After Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Participants will answer a questionnaire evaluating their individual opinion about the Investigational Product used.
Questionnaire consists of 9 questions which should be answered in a 5-point scale of agreement (such as ranging from "Strongly Disagree" to "Strongly Agree").
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After Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Open emotional testimonial written by the participant at the end of IP use
大体时间：After Visit 4 (56+2 days) of IP use
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Consists of an open-ended, narrative question in which the participant provides a brief statement regarding their experience with the use of their respective Investigational Product.
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After Visit 4 (56+2 days) of IP use
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月2日
初级完成 (估计的)
2026年9月25日
研究完成 (估计的)
2026年9月25日
研究注册日期
首次提交
2026年6月1日
首先提交符合 QC 标准的
2026年6月25日
首次发布 (实际的)
2026年7月1日
研究记录更新
最后更新发布 (实际的)
2026年7月1日
上次提交的符合 QC 标准的更新
2026年6月25日
最后验证
2026年6月23日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.